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The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study

United States120 participantsStarted 2021-04-03

Plain-language summary

A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
✓.1. Subject has failed IV t-PA therapy
✓.2. Subject is contraindicated for IV t-PA administration
✓.3. IV-tPA given within 3 hours of symptom onset
✓. Age ≥18 and ≤ 85
✓. NIHSS score ≥ 8 and ≤ 25
✓. Prestroke mRS score of ≤ 1
✓. Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.

Exclusion criteria

✕. Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
✕. Cardiopulmonary resuscitation, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
✕. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
✕. Cerebral vasculitis
✕. History of severe allergy to contrast medium.
✕. Known allergy to NeVa materials (nitinol, stainless steel);
✕. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
✕. Systemic infection

What they're measuring

Recanalization rate of the occluded target vessel

Timeframe: During the procedure/surgery

Trial details

NCT IDNCT04514562

SponsorVesalio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08

View on ClinicalTrials.gov More Acute Ischemic Stroke trials